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OpenTrials
Completed

NCT Number: NCT02569892

Non-Damaging Photothermal Therapy of Non-exudative Age Related Macular Degeneration

This is a randomized controlled study of non-damaging photothermal macular grid laser versus sham laser therapy in patients with dry age-related macular degeneration (AMD) and large high-risk drusen. The goal of the study is to determine if this treatment will reduce macular drusen volume and also whether this might improve visual acuity or reduce the risk of conversion to advanced age-related macular degeneration defined as development of choroidal neovascularization or geographic atrophy.

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Key information

Conditions

Macular Degeneration Eye Diseases Retinal Degeneration Retinal Diseases Retinal Drusen

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Byers Eye Institute at Stanford University

Palo Alto, California, 94303, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Older than 60 years of age.
  • Male or female patients with nonexudative AMD with a drusen volume of of at least 0.03mm3 in the central 3mm circle
  • Adequate pupil dilatation and clear media to perform colour, red-free imaging and fundus fluorescein angiography, fundus autofluorescence imaging and OCT.
  • Able to give an informed consent.

Exclusion criteria

  • Presence of signs of advanced AMD, such as CNV, haemorrhages or macular atrophy based on OCT and fundus autofluorescence photography (FAF).
  • Previous macular laser treatment.
  • Any previous ocular condition that may be associated with a risk of developing macular oedema.
  • Vitreomacular traction determined clinically and /or by OCT, which in the opinion of the investigator, contributes to the macular oedema (associated or causing a detachment of the fovea).
  • Presence of other macular disease such as epiretinal membrane, macular telangiectasia.
  • Important known allergies to sodium fluorescein dye used in angiography.
  • Ocular or periocular infections.
  • Planned intra-ocular surgery within one year.
  • Patient is unavailable for follow-up visits.

Treatment and study plan

Pascal Retinal Laser Photocoagulator

Device

Sub-threshold macular laser treatment with Pascal laser Endpoint Management System

Primary outcomes

  1. Change in Macular Drusen Volume

    Time frame: baseline, 6, 12, and 24 months

    Mean change in macular drusen volume as measured on high-resolution spectral domain ocular coherence tomography (SD-OCT)

Secondary outcomes

  1. Change in Visual Acuity

    Time frame: baseline, 6, 12, and 24 months

    Mean change in best-corrected visual acuity as measured using early treatment diabetic retinopathy study (ETDRS) chart - average number of letters seen on chart

  2. Development of Geographic Atrophy (GA) or Choroidal Neovascularization (CNV)

    Time frame: 2 years

    Count of eyes that develop geographic atrophy or choroidal neovascularization by 24 months.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Bascom Palmer Eye Institute

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Oct 7, 2015
Registry last updated
Oct 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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